APPLICATION
ANDA206547
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-13
LATEST ACTION
2025-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IMATINIB MESYLATEPrescription
IMATINIB MESYLATE EQ 400MG BASE · TABLET · ORAL
IMATINIB MESYLATEPrescription
IMATINIB MESYLATE EQ 100MG BASE · TABLET · ORAL
Approval history
2025-04-02Labeling · Supplement 11 · standardAP
2023-08-16Labeling · Supplement 6 · standardAP
2023-08-16Labeling · Supplement 9 · standardAP
2023-08-16Labeling · Supplement 7 · standardAP
2023-08-16Labeling · Supplement 8 · standardAP
2021-03-25Labeling · Supplement 1 · standardAP
2018-08-13UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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